duloxetine

Generic: duloxetine hydrochloride

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name duloxetine
Generic Name duloxetine hydrochloride
Labeler pd-rx pharmaceuticals, inc.
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

duloxetine hydrochloride 60 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 43063-878
Product ID 43063-878_32d37947-fcd6-03fe-e063-6394a90a8ec3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090778
Listing Expiration 2026-12-31
Marketing Start 2013-12-11

Pharmacologic Class

Classes
norepinephrine uptake inhibitors [moa] serotonin uptake inhibitors [moa] serotonin and norepinephrine reuptake inhibitor [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43063878
Hyphenated Format 43063-878

Supplemental Identifiers

RxCUI
596934
UPC
0343063878903
UNII
9044SC542W

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name duloxetine (source: ndc)
Generic Name duloxetine hydrochloride (source: ndc)
Application Number ANDA090778 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 60 mg/1
source: ndc
Packaging
  • 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (43063-878-30)
  • 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (43063-878-90)
source: ndc

Packages (2)

43063-878-30 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (43063-878-30) 43063-878-90 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (43063-878-90)

Ingredients (1)

duloxetine hydrochloride (60 mg/1)

Linked Drug Pages (1)

Duloxetine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "32d37947-fcd6-03fe-e063-6394a90a8ec3", "openfda": {"upc": ["0343063878903"], "unii": ["9044SC542W"], "rxcui": ["596934"], "spl_set_id": ["471fec2a-ce5c-4f1a-954c-edf22999686c"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (43063-878-30)", "package_ndc": "43063-878-30", "marketing_start_date": "20180806"}, {"sample": false, "description": "90 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (43063-878-90)", "package_ndc": "43063-878-90", "marketing_start_date": "20200727"}], "brand_name": "Duloxetine", "product_id": "43063-878_32d37947-fcd6-03fe-e063-6394a90a8ec3", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Norepinephrine Uptake Inhibitors [MoA]", "Serotonin Uptake Inhibitors [MoA]", "Serotonin and Norepinephrine Reuptake Inhibitor [EPC]"], "product_ndc": "43063-878", "generic_name": "Duloxetine Hydrochloride", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Duloxetine", "active_ingredients": [{"name": "DULOXETINE HYDROCHLORIDE", "strength": "60 mg/1"}], "application_number": "ANDA090778", "marketing_category": "ANDA", "marketing_start_date": "20131211", "listing_expiration_date": "20261231"}